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Pharmaceutics
Special Issues
Recent Advances in Injectable Formulations
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Recent Advances in Injectable Formulations

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Physical Pharmacy and Formulation".

Deadline for manuscript submissions: closed (28 February 2026) | Viewed by 5747

Special Issue Editor

Prof. Dr. René Holm

E-Mail Website
Guest Editor
Department of Physics, Chemistry and Pharmacy, University of Southern Denmark, Campusvej 55, DK-5230 Odense, Denmark
Interests: drug formulation and delivery; long-acting injectables; physical pharmacy; lipid-based formulations; cyclodextrins
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

We are pleased to invite you to contribute to this Special Issue on injectable formulations—one of the most important types of formulation for a variety of biological modalities. This formulation approach contains options for delivery designs that ease the life of patients, e.g., long-acting injectables for systemic or local treatment administered intramuscularly or intravitreally. Innovations such as nanotechnology, biodegradable polymers, and bioresponsive delivery systems are paving the way in personalized medicine, enabling tailored treatments. This Special Issue highlights recent advances in the field of injectable formulations defined in a broad context.

This Special Issue aims to present some of the recent research within the field of injectable formulations, such as research on the formulation, formulation-driven pharmacokinetics, and manufacturing methods.

In this Special Issue, original research articles and reviews are welcome. Research areas may include (but are not limited to) the following: formulation development of injectable formulations, pharmacokinetic investigations, and manufacturing of injectable formulations

I look forward to receiving your contributions.

Prof. Dr. René Holm
Guest Editor

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 250 words) can be sent to the Editorial Office for assessment.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Pharmaceutics is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2900 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • parenteral
  • sterile
  • injectable
  • lyophillized
  • intravenous
  • intramuscular
  • subcutaneous
  • long-acting injectables
  • biologicals
  • pharmacokinetics

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Published Papers (3 papers)

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Research

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23 pages, 2895 KB  
Article
Development of Cannabidiol-Loaded PLGA Microspheres for Long-Acting Injectable Delivery: Evaluation of Poly(2-ethyl-2-oxazoline) as an Alternative to Poly(ethylene glycol)
by Thabata Muta, Haripriya Koppisetti and Sanjay Garg
Pharmaceutics 2026, 18(3), 336; https://doi.org/10.3390/pharmaceutics18030336 - 8 Mar 2026
Viewed by 889
Abstract
Background/Objectives: Current clinical evidence suggests that cannabidiol (CBD) demonstrates therapeutic potential in the management of chronic pain, particularly in conditions involving inflammation. However, its therapeutic potential is severely limited by poor oral bioavailability, extensive first-pass metabolism, and the need for frequent high-dose [...] Read more.
Background/Objectives: Current clinical evidence suggests that cannabidiol (CBD) demonstrates therapeutic potential in the management of chronic pain, particularly in conditions involving inflammation. However, its therapeutic potential is severely limited by poor oral bioavailability, extensive first-pass metabolism, and the need for frequent high-dose administration, which compromises patient adherence and tolerability. Long-acting injectable (LAI) delivery systems offer a strategy to overcome these limitations by providing sustained plasma concentrations and reducing dosing frequency. This study aimed to develop and optimise CBD-loaded poly (lactic-co-glycolic acid) (PLGA) microspheres for LAI delivery and to evaluate poly(2-ethyl-2-oxazoline) (POx) as a functional and biocompatible alternative to the conventionally used poly (ethylene glycol) (PEG). Methods: CBD-loaded microspheres were prepared using emulsion–solvent evaporation technique. The formulations were optimised based on entrapment efficiency (EE), drug loading (DL), particle size distribution, surface morphology, thermal behaviour, in vitro release kinetics, and cytocompatibility using NIH 3T3 fibroblasts. Multiple in vitro release methodologies, including dialysis bag, shaking-flask, and USP Apparatus IV, were evaluated to identify the most discriminative and practical approach for long-term release assessment. Results: The optimised POx-based microspheres demonstrated superior control over particle size, yielding significantly smaller and more uniform particles compared with PEG-based microspheres (124 ± 1.47 µm vs. 218 ± 13.5 µm, respectively). Differential scanning calorimetry (DSC) confirmed molecular dispersion of CBD within the polymer matrix. In vitro release studies demonstrated sustained drug release over 20 days. Conclusions: POx represents a promising alternative to PEG for the formulation of CBD-loaded PLGA microspheres, offering enhanced physicochemical stability and biological compatibility. This platform supports the development of safe and effective long-acting injectable CBD therapies and consideration of POx as an alternative to PEG. Full article
(This article belongs to the Special Issue Recent Advances in Injectable Formulations)
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Review

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32 pages, 711 KB  
Review
Recent Advances in Particle Design for High-Concentration Protein Suspension Injectables
by Yijing Huang, Chanakya D. Patil, Kinnari Santosh Arte, Jiaying Liu, Haichen Nie, Qi Tony Zhou and Li Lily Qu
Pharmaceutics 2026, 18(4), 450; https://doi.org/10.3390/pharmaceutics18040450 - 7 Apr 2026
Viewed by 914
Abstract
Subcutaneous administration has become an increasingly important route for delivering protein therapeutics, driven by patient convenience and the growing use of self-administration devices. However, conventional subcutaneous injection systems are typically limited to injection volumes of approximately 1–2 mL, posing significant formulation challenges for [...] Read more.
Subcutaneous administration has become an increasingly important route for delivering protein therapeutics, driven by patient convenience and the growing use of self-administration devices. However, conventional subcutaneous injection systems are typically limited to injection volumes of approximately 1–2 mL, posing significant formulation challenges for protein drugs requiring high therapeutic doses. Monoclonal antibodies (mAbs), for example, often require concentrations exceeding 100 mg/mL to enable subcutaneous delivery, which introduces challenges related to limited solubility, elevated viscosity, and an increased risk of physical and chemical instability. Therefore, high-concentration protein suspensions have emerged as a promising formulation strategy to overcome these limitations and enable subcutaneous administration of high-dose proteins. In such systems, therapeutic protein solid particles are suspended in vehicles in which they are insoluble, giving rise to unique considerations related to particle properties, protein stability, and suspension behaviors such as viscosity, injectability, and sedimentation. Accordingly, multiple particle production approaches have been explored to enable the development of ultra-high-concentration protein suspensions (>200 mg/mL). This review article aims to provide a comprehensive overview of particle formation techniques and the relationships between key particle properties and suspension performance attributes relevant to the development of high-concentration protein suspensions for injectable applications, as well as future directions in this field. Full article
(This article belongs to the Special Issue Recent Advances in Injectable Formulations)
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29 pages, 1338 KB  
Review
Sustained-Release Intra-Articular Drug Delivery: PLGA Systems in Clinical Context and Evolving Strategies
by Jun Woo Lee, Ji Ho Park, Geon Woo Yu, Jae Won You, Min Ji Han, Myung Joo Kang and Myoung Jin Ho
Pharmaceutics 2025, 17(10), 1350; https://doi.org/10.3390/pharmaceutics17101350 - 20 Oct 2025
Cited by 5 | Viewed by 3298
Abstract
Poly(lactic-co-glycolic acid) (PLGA) sustained-release systems for intra-articular (IA) delivery aim to extend joint residence time and reduce the reinjection frequency of conventional IA therapies. This review synthesizes current understanding of PLGA degradation, the acidic microenvironment inside degrading microspheres, and release behavior in joints, [...] Read more.
Poly(lactic-co-glycolic acid) (PLGA) sustained-release systems for intra-articular (IA) delivery aim to extend joint residence time and reduce the reinjection frequency of conventional IA therapies. This review synthesizes current understanding of PLGA degradation, the acidic microenvironment inside degrading microspheres, and release behavior in joints, and surveys clinical experience with extended-release corticosteroid depots alongside emerging platforms for nonsteroidal and biologic agents. To situate PLGA within the broader IA field, we briefly summarize selected non-PLGA sustained-release approaches—such as multivesicular liposomes, hyaluronic acid conjugates, and hybrid matrices—to contextualize comparative performance and safety. For proteins and peptides, central barriers include acidification inside degrading microspheres, aggregation during fabrication and storage, and incomplete or delayed release, as illustrated by glucagon-like peptide-1 analog formulations. Mitigation strategies span pH buffering, excipient-based stabilization, and gentler manufacturing that improve encapsulation efficiency and preserve bioactivity. Translation hinges on manufacturing scale-up and quality systems that maintain critical particle attributes and enable informative in vitro–in vivo interpretation. Clinically, prolonged symptom relief after single dosing has been demonstrated for corticosteroid depots (e.g., ~50% pain reduction over 12 weeks with a single PLGA–triamcinolone injection), whereas repeat-dose safety and indication expansion beyond the knee remain active needs best addressed through multicenter trials incorporating imaging and patient-reported outcomes. Consistent real-world performance will depend on controlling batch-to-batch variability and implementing pharmacovigilance approaches suited to long dosing intervals, enabling broader clinical adoption. Full article
(This article belongs to the Special Issue Recent Advances in Injectable Formulations)
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